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FDA 510(k)

Clarifi Imaging System

K-Number: K181623 · 2018-07-19

ApplicantModulated Imaging, Inc.
Decision Date2018-07-19
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Clarifi Imaging System is a medical device manufactured by Modulated Imaging, Inc.. It received FDA 510(k) clearance on 2018-07-19 under approval number K181623. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clarifi Imaging System?

Clarifi Imaging System is a medical device that received FDA 510(k) clearance on 2018-07-19. It is manufactured by Modulated Imaging, Inc.. The 510(k) number is K181623.

When was Clarifi Imaging System approved by the FDA?

Clarifi Imaging System received FDA 510(k) clearance on 2018-07-19, under approval number K181623.

What company makes Clarifi Imaging System?

Clarifi Imaging System is manufactured by Modulated Imaging, Inc..

What is the FDA product code for Clarifi Imaging System?

The FDA product code for Clarifi Imaging System is MUD.

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Modulated Imaging, Inc.

K153426Ox-Imager CS

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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